POZCOS PO CC Cream by Chang Ha Co.,Ltd / GreenCos co.,Ltd

Drug Details [pdf]

POZCOS PO CC CREAM- titanium dioxide, zinc oxide, octocrylene cream
Chang Ha Co.,Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

Octocrylene, Titanium Dioxide, Zinc Oxide

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Smoothly and evenly apply the appropriate amount of cream after cleansing and base makeup

Apply liberally and evenly 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.-2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

Inactive ingredients

WATER, ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, CETYL ETHYLHEXANOATE, ZINC OXIDE, PHENYL TRIMETHICONE, DIPROPYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, CYCLOPENTASILOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ETHYLHEXYL SALICYLATE, DIMETHICONE, 1,2-HEXANEDIOL, LOESS, NIACINAMIDE, OCTOCRYLENE, QUATERNIUM-18 BENTONITE, BEESWAX, 4-METHYLBENZYLIDENE CAMPHOR, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, GLYCERIN, SORBITAN OLIVATE, MAGNESIUM SULFATE, PORTULACA OLERACEA EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HEXYL LAURATE, OZOKERITE, CYCLOHEXASILOXANE, MINERAL OIL, PHENOXYETHANOL, ALOE BARBADENSIS LEAF EXTRACT, GINKGO BILOBA LEAF EXTRACT, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM STEARATE, POLYESTER-1, SILICA DIMETHYL SILYLATE, MICROCRYSTALLINE WAX, ALUMINUM STEARATE, FRAGRANCE, ADENOSINE, QUARTZ, BUTYLENE GLYCOL, CENTELLA ASIATICA EXTRACT, DISODIUM EDTA, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, ALLANTOIN, SODIUM HYALURONATE, LIMONENE, LINALOOL, ALUMINUM HYDROXIDE, BUTYLPHENYL METHYLPROPIONAL, HEXYL CINNAMAL, CAPRYLYL GLYCOL, CI 77492, CI 77491, CI 77499, MICA

40g

POZCOS PO CC CREAM
titanium dioxide, zinc oxide, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81397-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.8 g in 40 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.67 g in 40 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.13 g in 40 g

Ingredient Name	Strength
Inactive Ingredients
BEMOTRIZINOL (UNII: PWZ1720CBH)	0.4 g in 40 g
GLYCERIN (UNII: PDC6A3C0OX)	0.4 g in 40 g
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)	0.32 g in 40 g
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)	0.32 g in 40 g
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)	0.27 g in 40 g
HEXYL LAURATE (UNII: 4CG9F9W01Q)	0.27 g in 40 g
CYCLOMETHICONE 6 (UNII: XHK3U310BA)	0.14 g in 40 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.08 g in 40 g
GINKGO (UNII: 19FUJ2C58T)	0.07 g in 40 g
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)	0.07 g in 40 g
MAGNESIUM STEARATE (UNII: 70097M6I30)	0.05 g in 40 g
NIACINAMIDE (UNII: 25X51I8RD4)	0.8 g in 40 g
BENTOQUATAM (UNII: 7F465U79Q1)	0.59 g in 40 g
ENZACAMENE (UNII: 8I3XWY40L9)	0.4 g in 40 g
SORBITAN OLIVATE (UNII: MDL271E3GR)	0.4 g in 40 g
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	0.01 g in 40 g
OCTINOXATE (UNII: 4Y5P7MUD51)	2.8 g in 40 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	0.04 g in 40 g
ALUMINUM STEARATE (UNII: U6XF9NP8HM)	0.03 g in 40 g
CENTELLA ASIATICA (UNII: 7M867G6T1U)	0.01 g in 40 g
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)	0.01 g in 40 g
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)	0.01 g in 40 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)	0.21 g in 40 g
FERROSOFERRIC OXIDE (UNII: XM0M87F357)	0.03 g in 40 g
MICA (UNII: V8A1AW0880)	0.12 g in 40 g
ADENOSINE (UNII: K72T3FS567)	0.02 g in 40 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.01 g in 40 g
FERRIC OXIDE RED (UNII: 1K09F3G675)	0.16 g in 40 g
PEG-4 CAPRYLIC/CAPRIC GLYCERIDES (UNII: H45189YI2Q)	1.2 g in 40 g
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)	0.44 g in 40 g
OCTISALATE (UNII: 4X49Y0596W)	1.2 g in 40 g
DIMETHICONE 100 (UNII: RO266O364U)	0.93 g in 40 g
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)	2.4 g in 40 g
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)	1.8 g in 40 g
DIPROPYLENE GLYCOL (UNII: E107L85C40)	1.6 g in 40 g
CERESIN (UNII: Q1LS2UJO3A)	0.2 g in 40 g
MINERAL OIL (UNII: T5L8T28FGP)	0.08 g in 40 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.08 g in 40 g
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)	0.04 g in 40 g
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)	1.46 g in 40 g
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)	1.46 g in 40 g
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.82 g in 40 g
WATER (UNII: 059QF0KO0R)	8.5 g in 40 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81397-201-02	1 in 1 CARTON	02/01/2021	05/01/2021
1	NDC: 81397-201-01	40 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2021	05/01/2021

Labeler - Chang Ha Co.,Ltd (690395914)

Name	Address	ID/FEI	Business Operations
Establishment
Chang Ha Co.,Ltd		690395914	pack(81397-201)

Revised: 5/2021

Document Id: c34b1a74-eb4e-64a2-e053-2995a90aac0c

Set id: b83deffa-e80d-a06a-e053-2995a90a3db9

Version: 2

Effective Time: 20210527